MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA CRUCIATE RETAINING LEFT SIZE 9 PPS STANDARD FEMUR; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial left total knee arthroplasty.Subsequently, 7 days post implantation, the patient began to experience chest tightness.The patient was ultimately diagnosed with myocardial infarction requiring placement of 2 stents approximately 15 days post implantation.The event has now been documented within the study as resolved, no device deficiencies or abnormalities have been reported at the 3-month follow-up and all initial components remain implanted.
Additional Manufacturer Narrative
(b)(4).D11: 42532007501- tibia cemented 5 degree stemmed left size f - 66582501; 42512100810 - articular surface medial congruent (mc) left 10mm height - 66681601.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Side effects of the administration of anesthesia are a known cause of chest pain, ekg changes, and myocardial infarction (heart attack) during the intraoperative and postoperative recovery.Elective total joint patients typically have a cardiac workup prior to surgery to assess the patient¿s physical readiness for surgery, hence reducing their risk for these cardiac related complications.Patients are at the highest risk immediately post op but continue to be at risk for several weeks after the procedure.As the reported complaint indicated, a cardiac postoperative complication developed, and medical treatment was warranted to treat the complication.

• Brand Name: PERSONA CRUCIATE RETAINING LEFT SIZE 9 PPS STANDARD FEMUR
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20664897
• Report Number: 0001822565-2024-03547
• Device Sequence Number: 12887329
• Product Code: JWH
• UDI-Device Identifier: 00889024631335
• UDI-Public: (01)00889024631335(17)340303(10)66448273
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42508606601
• Device Lot Number: 66448273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White